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| Name | Class |
|---|---|
| Federal University of Minas Gerais | OTHER |
| Boehringer Ingelheim | INDUSTRY |
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Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF patients, despite effective, remains beyond desired levels because of interactions with food and fluctuations in blood levels. Because of a more stable anticoagulation state, Dabigatran may offer better protection against thrombotic phenomenon and, consequently, mitigate the process of cognitive and functional compromise.
This will be a prospective parallel study including two hundred atrial fibrillation patients > 65 years old and scoring CHADS2VASc > 1. Patients will be randomized to receive Warfarin (INR between 2 and 3) or Dabigatran (150 mg twice daily) for two years. After one year and at the end of the study, individuals will be evaluated regarding cognitive endpoints following the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards (Hachinski et al. Stroke 2006;37:2220-2241). The investigators will use the 60 minutes evaluation protocol complemented by the Montreal Cognitive Assessment (MoCA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Active Comparator | Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3. |
|
| Dabigatran | Active Comparator | Dabigatran 150 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Warfarin once daily, at fast, targeting INR between 2 and 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive impairment | Cognitive impairment at two years, independently of stroke or other cerebrovascular events. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with less important alteration in coagulation test as a Measure of Safety | Comparison of thrombin generation test between the two treatment groups. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Caramelli, Professor | Heart Institute, University of Sao Paulo, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Univeristy of Minas Gerais | Belo Horizonte | Minas Gerais | 30130100 | Brazil | ||
| Heart Institute - University of São Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36284318 | Derived | Caramelli B, Yu PC, Cardozo FAM, Magalhaes IR, Spera RR, Amado DK, Escalante-Rojas MC, Gualandro DM, Calderaro D, Tavares CAM, Borges-Junior FA, Pastana AF, Matheus MG, Brucki SMD, Rodrigues ACO, Nitrini R, Caramelli P. Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial. BMC Med. 2022 Oct 26;20(1):374. doi: 10.1186/s12916-022-02563-2. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Dabigatran | Drug |
|
|
| São Paulo |
| 05403-000 |
| Brazil |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |